Method for accessing an operative space

ABSTRACT

The invention provides, in one embodiment, a method for accessing an operative space within a patient. The method can employ a multifunctional, multi-piece medical device, such as for use with a vacuum lift shell. The method provides flow communication between the external environment and operative field inside the patient&#39;s body during medical procedures, including diagnostic, therapeutic and surgical procedures. The invention allows entry and exit of air or gas to help create and maintain the operative field. The invention can be used to provide an open and unobstructed working path, and allows the operative space to be maintained at ambient conditions of pressure and temperature.

This application cross-references related copending application “MedicalDevice for Providing Access” filed on even date herewith and havingattorney docket number END5255.

FIELD OF THE INVENTION

This invention is related to medical devices and methods, and morespecifically to methods useful in performing vacuum assisted surgery,such as laparascopic surgery without insufflation.

BACKGROUND OF INVENTION

A conventional minimally invasive procedure requires the use of gas(such as carbon dioxide) insufflation to lift the tissue or body wallfrom internal organs, thereby separating the body wall from the internalorgans to create an operative space to introduce various surgicalinstruments to conduct the procedure.

The following patents disclose various tools for medical or surgicalapplications: U.S. 20030065358A1, U.S. Pat. No. 6,120,437A1, U.S. Pat.No. 6,099,550A1, U.S. Pat. No. 5,865,802A1, U.S. Pat. No. 5,823,947A1,U.S. Pat. No. 5,797,939A1, U.S. Pat. No. 5,766,169A1, U.S. Pat. No.5,456,684A1, U.S. Pat. No. 5,336,220A1, U.S. Pat. No. 5,186,714A1,EP0614646B1, WO0193742A2.

The following patents disclose examples of medical devices, includingtrocar and instrument assemblies: U.S. 200383628A1, U.S. 20030060770A1,U.S. 20030023257A1, U.S. 20030004529A1, U.S. 20030004528A1, U.S. Pat.No. 6,582,441B1, U.S. 20020198554A1, U.S. 20020183775A1, WO9410898A1,JP11089851A, JP07047076A, JP05228160A, JP04263849A, JP04253852A.

Though insufflation is commonly used, non-gas based methods have beenproposed. For example, such methods may use mechanical devices whereinthe tissue is lifted externally or by provided internal stirrup likesupports of different mechanical assemblies to lift the tissue to createthe operative space without the use of gas. One method employs a vacuumactuated tissue lifting device. The following US patents areincorporated herein by reference for disclosure related to liftingdevices and methods, including vacuum lifting devices and methods: U.S.Pat. No. 6,042,539, U.S. Pat. No. 5,938,626, U.S. Pat. No. 5,893,368.

The method described in U.S. Pat. No. 6,042,539 describes a vacuum shelland provides a “dome” like operative field within the patient. Anoptical trocar having an obturator and cannula sleeve may be employedwith such a vacuum shell. However, there can be difficulties related touse of such a trocar with vacuum assisted surgery and/or surgery withoutinsufflation.

For instance, conventional trocars can have a working length that is notsufficient for such an application (working length can be defined as theactual length of the tubular section of a trocar below the sealingsurface of the trocar). On the other hand, a trocar with an increasedlength may be difficult to maneuver and may restrict movement during thesurgical procedure.

Additionally, it may not be desirable to use a conventional bladedtrocar with a vacuum shell or other vacuum lift device, due to thepossibility of accidental contact with internal organs during a first“blind” entry into the body cavity. Even if an optical obturator isemployed, skill is still required to introduce and monitor the positionof the trocar tip simultaneously. Also, introducing the camera assemblyinto the trocar obturator can result in a bulky (difficult to handle)assembly during the step of penetrating the body tissue.

Moreover, a conventional trocar which has a fixed length may not besuitable for all patients. Different patients can have differentthicknesses of the abdominal wall and/or the fatty layers associatedwith the abdominal wall. For example, a thin or normal weight patientmay require a trocar having a certain length, while a relatively obesepatient may require a longer trocar.

Another problem with using a conventional trocar in vacuum assistedsurgery is that when the trocar is inserted after the vacuum shell isplaced on the tissue, the trocar will first cut through the perforablemembrane of the shell, then pass into the patient's tissue. If the userattempts to penetrate the body wall without the application of vacuum tothe vacuum shell, body wall will tend to buckle under the penetrationforce, and it is possible that internal organs could be injured. On theother hand, if the conventional trocar is inserted after applying vacuumand obtaining a partial or full lift of the abdominal wall from theinternal organs, the internal body cavity and organs below the abdominalwall may also “lift”. Movement of the bowels under peristalsis canbecome sluggish due to the effects of anesthesia, which may lead to theformation of pockets of trapped gases. These trapped gases can expandunder vacuum, and may result in reduced operative space and increasedgas pressure in the lumens of the bowel. Also, in the case of abdominalsurgery, the time during which the intra abdominal cavity is undervacuum can lead to pulling of the diaphragm into the abdominal cavity,and can create a negative pressure in the thoracic cavity.

SUMMARY OF INVENTION

Applicants have recognized the drawbacks of the use of conventionaltrocars with vacuum lift devices, and that there is a need for animproved device for providing access to the inside of the body whenvacuum lift devices are employed. Applicants have recognized the needfor a multicomponent passageway for use as a fluid (e.g. air) conduitwith a vacuum shell. Applicants have also recognized the desirability ofsuch an assembly to be of sufficient length to take into account the gapbetween the tissue's external surface and the vacuum shell before vacuumapplication (approx. 75-100 mm) plus the tissue wall thickness to bepenetrated to access the intra operative space.

In one embodiment, the invention provides a medical device comprising amulticomponent passageway for providing access to an internal space in apatient, the device comprising a first elongate, hollow member havingproximal end, a distal end, and an internal lumen; a second elongatemember having an open proximal end, an open distal end, and an internallumen providing a passagweay extending therethrough; and

-   -   wherein the first member is releasably attachable to the second        member to provide a generally continuous internal lumen. The        distal end of the first member can be positioned intermediate        the proximal and distal ends of the second member upon        attachment of the second member to the first member.

In another embodiment, the invention provides an assembly comprising avacuum device for providing an operative space within a patient; and amulticomponent device for providing access from a point external of thevacuum device to a point within the patient. The multicomponent devicecan comprise detachable first and second members, the first member forproviding a first portion of an access passageway, and the second memberfor providing a second poriton of an access passageway.

In another embodiment, the invention provides a method for performing amedical procedure. The method can comprise the steps of separating oneportion of a patient's body from another portion of the patient's bodyto provide an operative space within the patient's body; and accessingthe operative space through a multicomponent passageway.

The multifunctional, multicomponent passageway device can provide bidirectional movement of air. The device and its method of use is suchthat it allows placement and access to the body cavity below the bodywall before the application of vacuum with a vacuum lift device, therebyavoiding the problems related to the body cavity being under vacuum, orbowel dilation. The multimember design can provide flexibility to varythe length of the device. The device and method of the present inventioncan avoid potential difficulties of a first blind entry by not requiringa forced penetration or use of a sharp or pointed end to penetratethrough the tissue.

A multicomponent passageway device of the present invention can helpassure that the operative space created by lifting is maintained atambient conditions (e.g. ambient pressure conditions). The device, dueto its inner lumen, can also be used for passage of camera and orinstruments including but not restricted to laparoscopic handinstruments during a procedure. The bi directional passage of air tomaintain the ambient conditions in the body cavity may be maintainedeven when an instrument is passed through the device. The device of thepresent invention can accommodate insertion of diagnostic probes, suchas, but not limited to, ultrasonic laparoscopic probes or catheter basedprobes through its inner lumen for intra-operative diagnosticprocedures. The device can also allow removal of excised or extirpatedtissue through its inner lumen during the surgical procedure (as itoffers an unobstructed pathway which is devoid of any valve or flowcontrol assembly such as is typically present in an conventional trocar)and without loss of operative space. The device according to the presentinvention, due to its open communication with the external ambientenvironment, can also provide venting of fumes which may be generatedduring use of electro surgical equipments for cutting or coagulation ofinternal tissue.

Upon release of vacuum and removal of the vacuum lift shell, themulticomponent passageway device of the present invention can alsoprovide a channel for easy release of any air trapped in pockets of theinternal body cavity. After release of vacuum and removal of the shell,the device can provide a channel for placement of a drainage catheter todrain body fluids post operatively. Also, if desired, a cannulacomponent can be left in the incision and closed with a substantiallytight cap, post operatively, to provide a port to the internal bodycavity for visualization for possible bleeding or any such postoperative complications.

Without being limited by theory, the multifunctional, multi memberconduit device provided by the present invention can be used in medicalprocedures such as but not limited to gasless minimally invasiveprocedures using an external vacuum actuated tissue lifting device, toprovide a passage way for bi directional movement of air to maintain theoperative field at ambient conditions of temperature and pressure, forintroducing instruments and medical camera etc, that may be used duringthe operative procedure i.e. diagnostic, therapeutic or surgical, forremoval of extirpated/excised tissue, for clearance of fumes generatedduring use of electro surgical device, for cutting or coagulation etc,and for drainage of body fluids intra-operative or post operatively.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 is a schematic plan view illustration of a medical deviceaccording to one embodiment of the present invention.

FIG. 2 is a cross section view along the long axis of the device in FIG.1.

FIG. 3 is a schematic plan view illustration of a cannula extensionaccording to one embodiment of the invention, wherein the distalpiercing tip is closed.

FIG. 3A is schematic illustration of the distal end of the cannulaextension according to an alternative embodiment of the presentinvention, the cannula extension having a flexible distal portion withan open distal end, such as along a slit, to provide for instrumentpassage.

FIG. 3B is a schematic illustration showing the flexible distal portionof FIG. 3A joined to a proximal tubular portion of the cannulaextension.

FIG. 4 is the bottom view from the distal end of the cannula extensionof FIG. 3

FIG. 5 is a side elevation view of the cannula extension of FIG. 3 ofthe device.

FIG. 6 is a cross section view along the long axis of FIG. 5.

FIG. 7. is a top view from proximal end of a cannula according to oneembodiment of the present invention.

FIG. 8 is a schematic side elevation view of a cannula according to oneembodiment of the present invention.

FIG. 9 is the front elevation view of the cannula of FIG. 8.

FIG. 10 is the cross section view of the cannula along its long axis.

FIG. 11 is a schematic cross-sectional illustration of an alternateembodiment of a cannula extension member according to the presentinvention, the cannula extension having a non-circular, generally ovalcross-section.

FIG. 12 is the top view from the proximal end, showing the generallyoval cross section of the cannula extension in FIG. 11.

FIG. 13 is a side elevation view of a cannula extension having anon-circular cross-section.

FIG. 14 is a bottom view from the distal end of the cannula extension ofFIG. 13.

FIG. 15 is a schematic illustration of a cannula having a non-circular,generally oval cross section.

FIG. 16 is a bottom view from the distal end of the cannula of FIG. 15,showing a schematic representation of a laparoscope passing through theinner lumen of the cannula, and illustrating the resulting gap to theleft and right of the laparoscope due to the non-circular cross-section,thereby providing channels to the left and right of the laparoscopethrough which air or another instrument may pass.

FIG. 17 is a front elevation of the cannula of FIG. 15, and alsoschematically illustrating a laparoscope entering the proximal end ofthe cannula and passing through the internal lumen along the entirelength of the body and exiting out at the distal beveled tip of thecannula.

FIG. 18 is a top view of a cap according to one embodiment of thepresent invention.

FIG. 19 is a front elevation of the cap of FIG. 18.

FIG. 20 is a cross section of the cap of FIG. 18.

FIG. 21 is a perspective view of a patient lying on a procedure tableand an incision made through a body wall such as the abdominal wall togain access to a body cavity such as the abdominal cavity wherein theoperative space is to be provided.

FIG. 22 is a schematic illustration showing a cannula of the presentinvention positioned to extend through the incision in the body wallwith the beveled end of the cannula positioned in the body cavity, andwith air passageways in the form of eyelets disposed proximally of thebeveled end also positioned below the body wall and in the body cavity.

FIG. 23 is a perspective view of the vacuum shell to be used to lift thebody wall/tissue positioned over a portion of the patient through whichthe cannula extends, wherein the distal piercing tip of the cannulaextension is depicted as being used to penetrate a perforable membraneof the vacuum shell, and showing positioning the distal tip of thecannula extension to align with the proximal end of the cannula, suchthat the distal tip of the cannula extension can be positioned withinthe cannula, and such that the cannula extension can be releasablyattached to the cannula.

FIG. 24 is a schematic illustration of the multiple component device ofthe present invention assembled and in operative association with thevacuum shell, with vacuum being provided to lift the patients body walland provide an operative space intermediate the body wall and internalorgans, with arrows in various locations depicting the direction of flowof air, such as for instance, air entering the body cavity through theair passageway provided through the assembled cap, cannula extension,and cannula of the present invention.

FIG. 25 is a perspective view, which schematically illustrates theoperative space created by the use of vacuum shell and themultifunctional access device of the present invention, FIG. 25illustrating detaching the cannula extension from the cannula once liftis provided, and the cannula partially withdrawn in a proximal directionto position the beveled distal end of the cannula extension just belowthe body wall.

FIG. 26 is a perspective view illustrating the cap releasably attachedto the cannula, and the cannula being used to provide access through thevacuum shell and the patient's body wall into the body cavity, and witha sleeve employed about the cannula to maintain an air seal between thecannula and the exterior of the patient's body such that operative spacemay be maintained.

FIG. 27 is a bottom view of a sealing sleeve showing a flange surfacearea which can be provided with an adhesive.

FIG. 28 is the front elevation of the sealing sleeve.

FIG. 29 is a cross section view of the sealing sleeve.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

By the term “elongate” or “elongated” it is meant that a component ormember has a length at least three times its width (e.g. a cylinder witha length at least three times the outer diameter).

The terms “procedure” or “operative procedure” mean medical procedures,including without limitation exploratory, diagnostic, therapeutic,surgical, ambulatory or mobile, emergency, and post mortem procedures,either open or laparoscopic or laparoscopically assisted.

The term “operative space” means any working space created within thebody, such as below any tissue or an organ by relative separation, suchas by lifting partially or fully one body structure relative to another.

By “releasable attachment” and “releasably attachable” it is meant twoor more components can be repeatedly joined and separated withoutbreaking, distorting, damaging, or impairing the function or form of thecomponents.

The term “distal” is used to refer to the portion, part, end, or tip ofa component or member which is away from the user, while the term“proximal” is used to describe the portion, part, end, or tip which iscloser to the user of the device.

For purposes of explanation, the figures and the description areprovided with respect to an example of a procedure employing lifting ofthe abdominal wall, but it will be understood the invention can haveapplicability to other parts of the patient's body. In particular, butwithout limitation, the present invention can have applicability toprocedures in which external portions of the body are lifted withrespect to internal portions of the body to create an operative space.

While the vacuum shell and vacuum are described as examples of a mean oflifting the body tissue, it will be understood the appended claims arenot limited to applications involving the vacuum shell disclosed andillustrated below. For example, other lifting methods, includingmechanical, electromechanical, gas based or non gas based can beemployed with the device of the present invention.

While the description and figures depict threaded engagement featuresfor releasably attaching components, it will be understood othersuitable engagement features can be employed, including withoutlimitation friction fitting, snap fit features, press fit features, andelectrical or electro mechanical attachment means.

An assembled medical device 30 according to one embodiment of thepresent invention is shown in FIGS. 1 and 2. The medical device 30 caninclude a first elongate, hollow member and a second elongate, hollowmember which are releasably attachable, one to the other. The firstelongate member can comprise a cannula extension 132. The secondelongate member can comprise a cannula 233. The medical device 30 canalso include a third member, which can be releasably attacheable to oneor both of the cannula extension 132 and the cannula 233. In FIGS. 1 and2, the third element can comprise a cap 331. The device 30 can alsoinclude a sleeve 434 for providing sealing.

Each of the cannula extension 132, cannula 233, and cap 331 can beformed of any suitable biocompatible material. In one embodiment, themembers 132, 233, and 331 can be formed of a relatively rigid or semirigid non collapsible biocompatible material which can be translucent,transparent, or opaque. In one embodiment, each of the members 132, 233,and 331 can be transparent. Each member may be made by extrusion orinjection molding or any suitable plastic processing method or othersuitable manufacturing method. In one embodiment, each of the members132, 233, and 331 can be formed of polycarbonate, impact modifiedacrylic, actyl butydene styrene (ABS), or polyethyl ether ketone (PEEK).

The medical device 30 can also comprise the fourth member, sealingsleeve 434. Sealing sleeve 434 can be formed of a relatively flexiblematerial, such as a flexible polyurethane, silicone, polypropylene,polyisoprene, or rubber. Sealing sleeve 434 can be disposed about theouter surface of cannula 233, such that sleeve 434 fits snugly about theouter diameter of the cannula 233.

Referring to FIGS. 3-6 and FIGS. 11-14, the cannula extension 132 canhave any suitable cross-section, including circular and non-circularcross-sections. The cannula extension 132 can have an open proximal end142 and a distal end 144 which may be open or closed. The cannulaextension can include an internal lumen 140 which extends from aproximal end 142 to a distal end 144 of the cannula extension 132. Boththe cannula extension and the internal lumen can have circular crosssections, as shown in FIG. 3-6, or non-circular, generally ovalcross-sections as shown in FIGS. 11-14. Alternatively, the cannulaextension 132 could have a generally cylindrical outer surface, and theinner lumen 140 could have a non-circular cross-section. The cannulaextension 132 is shown as a single, unitary component, but cannulaextension 132 could be in the form of multiple components if desired.

The cannula extension 132 can have a length (as measured from theproximal end to the pointed tip 138) of at least about 100 mm(millimeters), and in one embodiment the length of the cannula extensioncan be between about 100 mm and about 175 mm, and can be at least aboutsix times the outer diameter of the cannula extension 132. The outerdiameter of the cannula extension 132 can be about 15 mm, and the insidediameter of lumen 140 can be about 12.75 mm, such as to accommodate 10mm sized hand instruments. Without being limited by theory, when 10 mmsized instruments are to be employed, it is believe that it can bedesirable to have an inner diameter of at least about 12.75 mm toprovide flow area around instruments introduced through lumen 140. If anon-circular lumen is employed, a inside lumen with an inside dimensionof at least 12.75 mm can be employed to provide flow around such anintroduced instrument (e.g. if an oval or elliptical shaped crosssection is employed, it can be desirable to have the major axis be atleast about 12.75 mm, and the minor axis to be at least about 11 mm). Itwill be understood that the outside and inside diameters may be variedfor different applications (e.g. reduced for smaller diameter 5 mm or 3mm minimally invasive instrument sets).

The cannula extension 132 can include a pointed tip 138 associated withdistal end 144. The pointed tip 138 can be provided for piercing througha portion of a vacuum shell membrane. The main body portion of cannulaextension 132 can have a generally cylindrical outer surface, and adistal portion of cannula extension 132 can have a tapered, generallyconical outer surface as shown in FIGS. 3 and 5. One or more lateralopenings 137 (or “windows”) can extend through the wall of the tapereddistal portion of the cannula extension 132 to provide communicationfrom the inner lumen 140 through the outer surface of the cannulaextension 132. The openings 137 can be positioned proximally of thepointed tip 138 at distal end 144, just above the pointed tip 138. InFIG. 3, two openings 137 are positioned about 180 degrees apart aroundthe outside surface of the tapered distal portion of the cannulaextension 132.

The openings 137 can have any suitable shape. It can be desirable thatthe openings 137 have a combined surface area of at least about 30square millimeters to provide sufficient air passage, such as to help inavoiding the occurance of a negative pressure (vacuum) inside the bodycavity.

Cannula extension 132 can also include an attachment portion 139 forreleasably attaching the cannula extension 132 to the cannula 233. Theattachment portion 139 can be in the form of external screw threads forallowing the cannula extension 132 to be releasably attached to thecannula by threaded engagement in screw-like fashion, though otherattachment means (e.g. latching mechanisms, press fits, snap fits, andother releasable fastening devices) could be employed. The attachmentportion 139 can be provided to prevent leakage of air at the juncture ofthe cannula extension 132 and the cannula 233. The cannula extension 132can also include an attachment portion 141 positioned at the proximalend 142 of the cannula extension 132. The attachment portion 141 can beprovided to releasably attach the cap 331 to the proximal end of thecannula extension 132. The attachment portion 141 can be in the form ofinternal screw threads, as shown in FIG. 6.

FIG. 3A illustrates an alternative embodiment of a cannula extension 132having an open distal end. In FIG. 3A, the cannula extension 132 isshown having a bifurcated distal portion 160 comprising a first tipportion 162 and a second tip portion 164. The bifurcated distal portion160 can be formed by cutting or otherwise forming the distal end of thecannula extension 132. For instance, the distal end of the cannulaextension 132 can be cut or formed to have a slit 167 extendinggenerally parallel to the axis of the cannula extension 132 to generallybisect the distal end of the cannula extension 132. The distal portion160 can be formed of a flexible material, such rubber, silicone rubber,or a suitable flexible polymeric material so that tip portions 162 and164 can be easily spread apart (as shown in phantom in FIG. 3A). FIG. 3Aillustrates how bifurcated distal portion 160 can be separated to allowintroduction of a laparoscope 1012 (shown in phantom) therethrough.

Referring to FIG. 3B, the proximal portion of the cannula extension 132can be formed from a generally cylindrical, relatively rigid andgenerally transparent polycarbonate tube 180, and the distal portion 160can be formed of rubber or other relatively flexible material, withdistal portion 160 being joined to the tube 180 at a flexible hingeportion 170. Hinge portion 170 can have a corrugated or bellows-likewall construction to provide for bending of distal portion 160 relativeto the polycarbonate tube 180. Hinge portion 170 can be attached to tube180 by any suitable method, including without limitation by interferencefit, press fit, snap fit, adhesive, or by threaded engagement. Ifdesired, one or more surfaces on the distal portion 160 can be employedto provide sealing engagement with an abutting surface on the cannula233. For instance, one of the inclined surfaces on the hinge portion 170can be used to form a seal against an abutting surface on the cannula233. Also, in an alternative embodiment, the grooves of the hingeportion 170 can be employed to mate with complimentary grooves which canbe provided on the cannula extension 132 to provide releasableattachment of the cannula extension 132 and the cannula 233.

FIGS. 2 and 7-10 illustrate a cannula 233 according to one embodiment ofthe present invention. The cannula 233 can have any suitable crosssectional shape (e.g. circular or non-circular, such as oval), whichcross-sectional shape can be the same as, or different from the crosssectional shape of the cannula extension 132. The cannula 233 can have aproximal end 238 and a distal end 236, with an internal lumen 242extending from the proximal end to the distal end. The cannula 233 canhave any suitable cross sectional shape, including circular andnon-circular cross-sections (e.g. oval) as shown in FIGS. 7-10 and FIGS.15,17. The distal end 236 can be beveled to form a beveled tip, as shownin FIGS. 8-10, for easy entry through any incision. The wall thicknessof the cannula can be uniform or can vary along the length of thecannula. For instance, the wall thickness at the distal end 236 may bevaried for easy penetration through an incision.

The cannula 233 can have a length of at least about 100 mm, and in oneembodiment the cannula has a length between about 100 mm and about 175mm. The length of the cannula 233 can be greater than, less than, orsubstantially the same length as that of the cannula extension 132. When10 mm size instruments are to be introduced through the cannula 233, theoutside diameter of the cannula can be about 15 mm, and the insidediameter of the internal lumen 242 can be at least about 12.75 mm. Thedimensions of the cannula 233 can be varied, such as by being reducedfor use with smaller 5 mm or 3 mm instrument sets. Generally, it isdesirable that the outer diameter and shape of the cannula and thecannula extension be substantially the same to avoid leakage through thevacuum shell membrane. In one embodiment, the minimum inner diameter ofboth the cannula and the cannula extension can be at least about 12.75mm to provide a continuous, uninterrupted air passageway with or withoutinstruments extending through the cannula and cannula extension.

The cannula 233 can include one or more lateral openings through thewall of the cannula, such as circular eyelets 235. For instance, two ormore circular eyelets 235 can be spaced at generally equal angularintervals around the circumference of outside surface of cannula 233. Ifdesired, a relatively larger eyelet 235A can be positioned along thelongest side of the beveled tip 236, as shown in FIG. 2. The eyeletsextend through the wall of the cannula and provide fluid (e.g. gas suchas air) communication from internal lumen 242 to the outside of thecannula. The eyelets can be positioned proximally of the beveled tip,and in one embodiment the eyelets 235 can be spaced a maximum of about5-10 mm from the edge of the beveled tip as measured parallel to theaxis of the cannula 233. The eyelets can provide an air passageway forair from cannula extension 132 through cannula 233 and into the internalbody cavity in the event the distal end 236 of cannula is blocked forany reasons (e.g. such as by end 236 being positioned against a tissueor organ mass).

The cannula can also include an attachment portion 243, such as internalgrooves or an internal threaded portion for releasably attaching theproximal end of the cannula 233 to the cannula extension 132. Attachmentportion 243 can have screw threads, grooves, or other features forreleasably engaging with external surface features (such as externalscrew threads) on cannula extension 132. Attachment portion 243 can alsobe used for releasabley attaching the cap 331 to the proximal end ofcannula 233.

FIGS. 18-20 illustrate a cap 331. The cap 331 can include a main bodyportion 357 and an attachment portion 356 such as an external threadedportion. The relatively large outside diameter of body portion 357provides a handle for gripping by the user. External threaded portion356 can be formed to engage the threaded portions of the cannulaextension 132 and the cannula 233, such that cap 331 can be releasablyattached to the proximal end of either cannula extension 132 or cannula233. The cap 331 can have an internal, central bore 358 which can be ofsubstantially the same size (e.g. same diameter) as the internal lumen140 and the internal lumen 242. The central bore 353 together withinternal lumen 140 and internal lumen 242 can provide a continuous airpassageway from outside the patient to the internal operative spacewithin the body.

FIGS. 27-29 illustrate a sealing sleeve 434 according to one embodimentof the present invention. The sleeve 434 has a generally cylindricalbody portion 436 and a flange portion 468 extending radially from thedistal end of the cylindrical body portion 436. A central bore 470extends through sleeve 434. Central bore 470 can be sized so that sleeve434 can snugly fit around and slide along the length of the outsidesurface of cannula 233. The sleeve can be formed of a relativelyflexible material such as rubber, so that flange portion 468 can contourto contours of the patient's body. A bottom surface 469 of the flange468 can be coated with or otherwise provided with an adhesive, such as apressure sensitive adhesive coating or other suitable adhesive. Arelease liner (not shown) can be used to cover the adhesive prior totime of use, and the release liner can be pealed from the flange surfaceat the time of use to expose the adhesive coating. The adhesive coatingprovided on surface 469 can be used to temporarily attach the sleeve 434to an outer surface of the patient's body, so that flange 468 helps insupporting the cannula 233 when the cannula is inserted into an incisionin the patient's body. The surface 469 can also be provided with amedicinal substance, such as a medicinal substance selected from thegroup of substances consisting of hemostatic substances, anti-microbialsubstances, antibacterial substances, pain reducing agents, andcombinations thereof.

FIGS. 11-14 illustrate an alternative embodiment of a cannula extensionlabeled with reference number 1044. Cannula extension 1044 is shownhaving a generally oval shaped cross-section and an internal lumen 1045having a generally oval shaped cross-section. FIGS. 15,16 & 17illustrate an alternative embodiment of a cannula labeled with referencenumber 2049. Cannula 2049 is shown having a generally oval shapedcross-section and having an internal lumen 2052 having a generally ovalshaped cross-section. The cannula extension 1044 can be releasablyjoined to cannula 2049.

Employing internal lumens having oval cross-sections or othernon-circular cross-sections may be advantageous for accommodatinginstruments having a large width dimension that can be inserted so thatthe large width dimension is aligned with the long axis of the ovalcross-section. An oval cross-section may also be useful forsimultaneously receiving multiple instruments, such as in side by siderelationship. An oval cross-section may also be useful in retrievinglarger tissue samples through the cannula 2049. An oval cross-sectionmay also aid in reducing the stretching of tissue around the incision inthe patient. Referring to FIGS. 16 and 17, the non-circularcross-section of lumen 2049 can also leave gaps 2055 on either side of acircular instrument 2050 inserted in the lumen, so that an air passageis maintained through the cannula 2049 even when the instrument ispositioned in the lumen 2049. The relatively large cross-sectionprovided by an oval shape can also provide for a larger flow volumethrough the lumen 2049, which may be desirable in applications wherefast air pass or a large quantity of air is required. For example, whenthe tissue is lifted with a vacuum shell using a very high capacityvacuum, if the air passageway is not large enough, a partial vacuumeffect may be created inside the body cavity for a short period of time.A non-circular design such as an oval shaped cross-section can avoidsuch a partial vacuum effect by providing gaps 2055 around theinstrument 2050, as well as providing a large flow area when theinstrument is not present.

An non-circular cross-section such as an oval cross-section can beemployed to accommodate an instrument which would not pass through acircular cross-section having an internal diameter comparable to theminor dimension of the non circular cross-section. Alternatively, anoval cross section may also be employed to accommodate multipleinstruments of smaller profiles simultaneously. An oval or non-circularcross-section may also be useful for use in extracting relatively largeexcised tissue through the cannula and cannula extension. Thenon-circular cross-section can cause the tissue to be squeezed in onedirection while allowing it to expand in the other when passing throughsuch a cannula and cannula extension. Without being limited by theory,an oval or similar non-circular cross-section may also reduce thestretching of the tissue around the incision 59 through which it passes.Further, a non-circular shape may be employed to provide larger area forpassage of air and thus help in applications where fast air pass or alarger quantity of air passage is desired (for example when the tissueis lifted by using a very high capacity vacuum, if the lumen of deviceis not large enough, a partial vacuum effect may be created inside thebody cavity for a short period of time. A non-circular lumencross-section can be employed to avoid such a partial vacuum byproviding a relatively large flow area even when the instrument 51 ispresent.

The method of use of the multifunctional device 30 is illustrated inFIGS. 21-26. As shown in FIG. 21, with the patient lying on his/her backduring the procedure, an incision 59 can be made through the body wall60 (or other tissue which is to be lifted) to obtain access to theinternal body cavity 67. Once the incision is made, it is kept openusing artery forceps or retractors and the cannula 233 of themultifunctional device 30 can be introduced into the body cavity 67 suchthat beveled tip 236 and the multiple eyelets 235 are all disposedinside the body cavity. Markings can be provided on the external surfaceof the cannula 233 to help the surgeon determine the depth of insertionto avoid leakage of air or slippage of the cannula extension into thebody cavity. If desired, the outside surface of the cannula 233 caninclude grooves or ridges (such as coaxial ring grooves along a lengthof the outside surface of the cannula 233) to help prevent slipping ofthe cannula 233 in the incision, and to help provide an air seal betweenthe borders of the incision and the outer surface of the cannula 233.

Once the cannula extension is inserted to the required depth, incisionmay be sutured using a purse string technique to make it air tightaround the cannula extension 233. Additional the sealing sleeve 434 canbe slid downwards over the cannula extension 233 towards the incision59. The protective release liner can be removed from the adhesive coatedsurface 469 of flange 468 on the sleeve 434. The flange 468 can then bepressed onto the external surface of body wall 60 surrounding theincision 59 to make it airtight. In addition to the adhesive coating,the surface 469 may also be coated with other active agents such as antimicrobial agents, wound healing agents, hemostatic agents, and the likefor additional activity and use of the sealing sleeve. Alternativelyinstead of an adhesive coating a gel like coating may also be used tomake the seal substantially air tight. In addition to providing sealingat the incision, the sleeve 434 can also help stabilize the cannulaextension 233 in place.

Once the incision is made sufficiently airtight, the vacuum shell 61 isplaced on the outside surface of the body wall 60 (e.g the outer skinoff the abdomen) such that at least one perforable membrane 62 of thevacuum shell is above the cannula extension 233 as shown in FIG. 23. Thepointed tip 138 of the cannula extension 132 can be used to penetratethe perforable membrane 62 of the vacuum shell to form an opening 63 inthe membrane 62 (FIG. 23). The cap 331 can be joined to the cannulaextension 132 and can serve as a handle to provide grip for advancementof the cannula extension 132. The cannula extension 132 can then bepushed distally toward the incision and aligned with the proximal end ofthe cannula 233. The pointed tip 138 can be inserted into the cannula233, and the extension 132 can be releasably attached to the member 233,such as by threaded engagement, friction fit, or any other suitablereleasable attachment mechanism, thereby providing an assembly of thecannula 233, the extension 132, the sleeve 434, and the cap. With thecomponents assembled, vacuum can be provided to the vacuum shell. 61.

Vacuum applied using the shell 61 results in air being drawn from thespace 66, as illustrated by the arrows in FIG. 24. The vacuum causesbody wall 59 to lift upwards towards the shell 61. Simultaneously, airfrom the external ambient environment can enter body cavity 67 throughdevice 30, by passing through the inner lumens of the hollow cannula 233and the hollow cannula extension 132. Air can enter into the device 30through the cap 31, pass through its inner lumen 458, then through innerlumen 140 of cannula extension 132. The air can then pass through thedistal end of extension 132 by passing through the fluid passage windows137, to enter lumen 242 of the cannula 233. The air can then flow intothe body cavity through the beveled tip 236 and/or through the pluralityof eyelets 235/235A.

The amount of air drawn into the body cavity depends, to some extent, onthe size of the inner lumen of the device 30 as assembled, as well asthe size of the windows 137 and the opening at the beveled tip 236, andthe rate and level of vacuum applied to the vacuum shell. By providing acontinuous fluid passage through the assembled device 30, the air drawninto the body cavity 67 will be sufficient to balance the effect of thevacuum applied by the vacuum shell and to maintain body cavity 67 at anambient condition of pressure and also avoid any lifting or bloating ordistension of internal organs 65 below the body wall.

Cap 31 can be employed to help avoid slippage of the device 30 into thebody cavity or below the shell 61. During the entire procedure themultifunctional, multicomponent device 30 can serve to providecommunication path for fluids and/or devices from the externalenvironment outside the patient to the internal body cavity 67.

As complete vacuum lift is obtained, the external surface of the bodywall 60 can contact the internal surface of the vacuum shell 61 as shownin FIG. 25. Due to this lift an operative space is created in the bodycavity 67. The device 30 as assembled in FIG. 24 can then be retractedproximally as shown in FIG. 25 until the junction of the cannula 233 andthe cannula extension 132 is postioned externally of the perforablemembrane 62 of the shell 61. Cap 331 can be grasped for pulling thedevice 30 proximally. Depth markings on the external surface of cannula233 can be used to a minimum desirable length of the cannula 233 remainswithin the space in the body cavity 67.

The cannula extension 132 can be detached from the cannula 233, and cap331 can be detached from cannula extension 132 and releasably attachedto cannula 233. The reconfigured device 30 now comprises the cap 331releasably joined to the proximal end of the cannula 233, as shown inFIG. 26. Cannula 233 provides a flow passage for ambient air pressure tobody cavity 67. Additionally, various medical devices, such asendoscopic medical devices, can be introduced into body cavity 67through the cap 331 and cannula 233.

The cannula 233 positioned as shown in FIG. 26 can provide a number offunctions, including without limitation: providing bi-directionalpassage of air to maintain an ambient condition inside operative spacethe body cavity 67; venting of fumes and odors that may be generated dueto cauterization of internal organs 65 to maintain good visibilityinside the operative space; permitting multiple instrument exchangewithout loss of operative space; maintaining the incision open andthereby provide continuous access to the internal body cavity 67;permitting simultaneous passage of two or more instruments through thecannula 233; removal of tissue or body fluid from the operative throughthe cannula 233 (possible in part because a valve is not required as isneeded in a typical cannula); and introducing medications or diagnosticprobes through the cannula 233 either during the procedure or postoperatively.

When the procedure is complete, the vacuum associated with the vacuumshell 61 can be released, so that body wall 60 drops to its originalconfiguration. The cap 331 can be detached, and the shell 61 can beremoved while keeping cannula 233 in place in the incision 59. Thecannula 233 can be used to introduce a drainage catheter before finalremoval or closure of incision 59. Alternatively, it may be fitted witha new solid non-hollow cap similar to cap 331 but without the innerlumen 358 to provide an access conduit that is sealed from ambientconditions and which can then be used for visualization of the proceduresite within the body cavity, such as for post operative inspection forany suspected bleeding or drainage until such time as the surgeondecides to close the incision.

While the present invention has been illustrated by description ofseveral embodiments, it is not the intention of the applicant torestrict or limit the spirit and scope of the appended claims to suchdetail. Numerous other variations, changes, and substitutions will occurto those skilled in the art without departing from the scope of theinvention. For instance, but without limitation, the multicomponentaccess device can be provided with a vacuum shell in kit form. Moreover,the structure of each element associated with the present invention canbe alternatively described as a means for providing the functionperformed by the element. It will be understood that the foregoingdescription is provided by way of example, and that other modificationsmay occur to those skilled in the art without departing from the scopeand spirit of the appended claims.

1. A method of performing a medical procedure comprising the steps of:separating one portion of a patient's body from another portion of thepatient's body to provide an operative space within the patient's body;and accessing the operative space through a multicomponent passageway.2. The method of claim 1 wherein the step of separating compriseslifting one portion of the patient's body relative to another portion.3. The method of claim 1 wherein the step of separating comprisesemploying vacuum.
 4. The method of claim 1 wherein the step ofseparating comprises associating a vacuum shell with a portion of thepatient's body.
 5. The method of claim 1 wherein the step of accessingthe operative space comprises providing positive air pressure to theoperative space through the multicomponent passageway.
 6. The method ofclaim 1 wherein the step of accessing the operative space comprisesproviding ambiant air to the operative space through the multicomponentpassageway.
 7. The method of claim 1 comprising disposing a first memberof the multicomponent passageway in an opening in the patient's body. 8.The method of claim 1 comprising disposing a first member of themulticomponent passageway in an opening in the patient's body, andreleasably attaching a second member of the multicomponent passageway tothe first member.
 9. The method of claim 1 comprising disposing a firstmember of the multicomponent passageway in an opening in the patient'sbody, positioning a vacuum device with the respect to the patient'sbody; and disposing a second member of the multicomponent passagewaysuch that the second member of the multicomponent passageway extendsthrough the vacuum device.
 10. The method of claim 1 comprisingdisposing a first member of the multicomponent passageway such that adistal portion of the first member is disposed within the patient's bodyand a proximal portion of the first member is disposed outside thepatient's body; and disposing a second member of the multicomponentpassageway such that the entire length of the second member is disposedoutside the patient's body.
 11. The method of claim 1 wherein a memberof the multicomponent passageway has a pointed tip selected from thegroup consisting of bifurcated and non-bifurcated tips.
 12. The methodof claim 1 wherein a member of the multicomponent passageway comprises arelatively rigid body portion and a relatively flexible distal endportion.
 13. A method of performing a medical procedure comprising thesteps of: forming an incision in a patient; inserting a cannula in theincision such that a proximal portion of the cannula is positionedoutside the patient and a distal portion of the cannula is positionedinside the patient; positioning a vacuum shell over the incision and thecannula; providing a cannula extension extending through the vacuumshell and communicating with the cannula.
 14. The method of claim 13comprising the step of releasably attaching the cannula extension to thecannula.
 15. The method of claim 13 comprising the step of providing airfrom outside the patient to an internal operative space inside thepatient through the cannula.